CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

iTotal Posterior Stabilized (PS) Knee Replacement System recalled

Conformis is recalling iTotal Posterior Stabilized (PS) Knee Replacement System, distributed in New Hampshire. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 0434436 and 0434836

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1079-2019
FDA event ID: 82101
Recalling firm: Conformis, Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2019
FDA classified: 30 Mar 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

4 Jan 2019	Recall initiated by company
30 Mar 2019	Classified by FDA	+85 days
10 Apr 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The labeling of the boxes and sterile pouches did not match the contents.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Where it was distributed

The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

New Hampshire

Questions about this recall

Why was it recalled?

The labeling of the boxes and sterile pouches did not match the contents.

Which lots are affected?

Serial Numbers 0434436 and 0434836

Where was it sold?

The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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